Record and verification method, apparatus and system

ABSTRACT

A method and apparatus are provided for verification of the identity of a patient undergoing treatment administered by a medical treatment practitioner in a treatment room. An identifying element such as patient chart or patient photograph is provided for the patient which includes a patient identifier, e.g., a barcode, capable of being read by a reader device located within the treatment room. In use, the patient identifier is read by the reader device in the treatment room and a characteristic audio signal, previously assigned to the patient and known to the patient, is generated in response to the reading of the identifying element when there is a match between the patient identifier and a stored identifier for the patient. Treatment of the patient is at least temporarily withheld if any audio signal generated in response to reading of the patient identifier by the reader device is not the characteristic audio signal assigned to the patient. A special patient chart with a removable identifier can be used. A billing method which may involve the scanning step is also provided.

REFERENCE TO PROVISIONAL APPLICATION

[0001] This application claims benefit of priority of U.S. ProvisionalApplication Ser. No 60/365,636.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application is a Continuation-in-Part of application Ser.No. 09/473,138 filed on Dec. 28, 1999.

FIELD OF THE INVENTION

[0003] The present invention relates to record and verify systems usedin medical treatments and, more particularly, to an improved record andverification system for such use which includes a number of importantfeatures and advantages as compared with prior art systems includingthose currently in use.

BACKGROUND OF THE INVENTION

[0004] By way of background, it is instructive to briefly consider thehistory of verify and record systems used in connection with radiationtherapy treatment of patients using linear accelerators or othermegavoltage radiation units. Verify and record systems were originallydesigned to verify that radiation treatments were set up correctly bythe radiation therapy technologist (RTT). This was accomplished throughverification that certain key parameters were within predeterminedtolerances. The verify and record process has evolved more recently intoan automated set-up procedure that emphasizes rapid through-put, whilede-emphasizing verification of treatment parameters that previously wereset manually by the RTT. Some record and verify systems currently in useactually take control of the manual process by changingphysician-selected field sizes, even though the field sizes fall withinselected tolerance limits. The trend toward automated systems has led toreduced interaction between the user and the accelerator which has bothpositive and negative implications. The philosophy of deliveringradiation treatment based on an automated set-up model is grounded inthe desire to reduce the potential for human error in the set-upprocess. The downside of the automated or “black box” approach is thedisengagement of the RTT from parameter adjustment, i.e., in relievingthe RTT of the task of setting the patient treatment parameters throughadjustment of the linear accelerator. The negative aspect of this isthat if the RTT does not have to set the parameters manually, the RTT isless conditioned to perform the function manually and, therefore, lessconditioned to detect errors when these errors occur, whether theseerrors are dosimetry programming or process errors and whether theseerrors occur in manual or automated set-up modes. When the RTT isdetached from the procedure of manually setting up the patient fortreatment, it becomes more difficult for the overall treatment processto recover should the automated process fail. In this regard, when anRTT sets up a patient manually, the RTT “rehearses” the recoveryprocedure that would be used if the automated primary process shouldfail. However, when automated set-ups are employed, the RTT is less“rehearsed” in recovering efficiently when the automated process is notavailable, because such rehearsal of recovery procedures is not integralto automated treatment delivery. The more safety critical the task, themore the recovery should be rehearsed.

[0005] Given current trends in the medical industry, the trend towardautomated set-up is irreversible. Further, because of a number offactors including cost pressures, the trend toward staffing reduction isirreversible, at least in the near term. It also appears clear that theelectronic record will not totally replace the paper chart, at least notin the near term. In this regard, even if it were proven better forpatient care to chart electronically, physician resistance will hinderwidespread adoption in the foreseeable future. In general, physicianswill not abandon paper charts, either from habit or for medical-legalreasons. Accordingly, the need for maintaining a paper record duringimplementation of electronic medical record keeping will continue. As aconsequence, a further vulnerability of automated radiation treatmentsystems (in addition to the disengagement of the RTT from the manualrecovery process when the automated system is temporarily down), is thepotential for mismatches between the electronic record and the papermedical record. These mismatches are commonly due to a failure of theRTT to document treatments in the paper record when the automated systemlogs the event. The problem of electronic record and paper mismatches isincreasing in the specialty of radiation oncology, as reported byclinical medical physicists.

[0006] It should be understood that disengagement of the RTT from themanual recovery process increases risk for patient care because theverify and record systems, in many recent configurations, do not checkfor human error. Record and verify systems, when programmed and executedcorrectly, can prevent some errors, but not all. Record and verifysystems in current use cannot detect human errors when the system itselfis the primary process. Additionally, as indicated above, thedisengagement of the RTT from linear accelerator parameter adjustmentalso can disengage the RTT from subtle cues regarding patientidentification and radiation field placement. It would be desirable ifrecord and verify systems were configurable to allow automated set-upsat selected times for certain radiation therapy technologists and notfor others, such as, for example, when the manual skills of selectedRTTs are being assessed However, the overall trend is clearly towardautomated set-up because of the improved throughput which results, aswell as the industry-wide momentum toward multi-leaf collimator therapy,which is more optimally performed with automation.

[0007] Greater automated throughput can lead to greater risk for otherreasons as well. Increased automation means greater potential for amistake occurring through dose calculation error, with the danger of theerror being repeated without prompt detection once the error does occur.The emphasis on throughput also increases the probability of errors inthe actual treatment process, characterized by patient identificationerrors, field sequence errors and field alignment errors. Majorpreventable ways to harm patients through treatment process failuresinclude (1) treating the wrong patient, i.e., treating a patient with aradiation treatment intended for another patient; (2) treating the rightpatient, but on a day when the patient is not supposed to receivetreatment until other evaluations are performed first (e.g., treating apatient when the patient should have been seen by the doctor prior tothe treatment delivery), and (3) treating the right patient but with theimproper treatment set-up, i.e., treating with a wedged field without awedge, treating with the wrong monitor units (MU) programmed into theaccelerator, or treating with the wrong energy. In addition, asdescribed above, in the event that the record and verify device shouldbe temporarily unavailable due to a network, or other, problem, there isa distinct possibility or even an increased probability of parameterselection errors due to human error, because the process of automationcan change the behavior of the user, making the user more dependent onautomation. It is noted that more combination chemotherapy withradiation increases toxicity and therefore increases the potential harmthat may occur to a patient if the patient receives the wrong treatmentor if the patient is treated without proper evaluation before treatment.Moreover, pushing patients to the limit of tissue tolerance increasesthe potential for adverse events. Automated treatment may increase thepossibility of undetected mistakes related to automated set-up, therebyincreasing the possibility of patient injury.

[0008] As indicated above, the transition to automated treatment systemtends to distract the RTTs for a number of reasons. First, and verybasically, the new technology creates a new process. Further, the newprocess diverts RTTs from traditional cross checks in the treatmentroom. This is true of systems now in use such as the VARIS, IMPAC andLANTIS systems. In addition, visual distractions are created and theRTTs are diverted from paper chart documentation which can be criticalin the safe treatment of a patient.

[0009] Although the focus above has been on radiation therapy, it willbe appreciated that similar problems exist in other medical treatmentsettings including chemotherapy as well as in neonatal care, dispensingof medications on both an inpatient and outpatient basis and in otherinpatient and outpatient applications wherein patient verification,medication verification, medication delivery device verification and thelike are of importance.

SUMMARY OF THE INVENTION

[0010] In accordance with the invention, a record and verify method isprovided which addresses the issues discussed above. Among otheradvantages, the method of the invention assists in verification ofpatient identity, and, according to an important feature, enlists thepatient in the identification process. The invention also documentselectronically and manually which RTT was responsible for finalparameter verification, including documenting the treated patient, andtime of cross-check, and thus avoiding electronic record and paperrecord mismatches. The patient identification component is installed ata workstation and functions even if the system network is down, therebymaintaining an accountability trail as part of the recovery procedurefrom network failure.

[0011] In accordance with a first aspect of the invention, a method isprovided for verification of the identification of a patient undergoingradiation treatment administered by a treatment technologist in atreatment room using a radiation source, the method comprising:

[0012] providing an identifying card for the patient including anidentifying optical code capable of being read by an optical readerlocated within the treatment room;

[0013] causing the identifying card to be read by said optical reader inthe treatment room;

[0014] generating a characteristic audio signal, previously assigned tothe patient and known to the patient and the treatment technologist, inresponse to the reading of the identifying card when there is a matchbetween the identifying optical code and a stored identifying code forthe patient; and

[0015] at least temporarily withholding treatment of the patient if thepatient and technologist do not agree that any audio signal generated isthe characteristic audio signal assigned to the patient.

[0016] In an advantageous implementation, the identifying card includesa photograph of the patient and the photograph is used by thetechnologist in identifying the patient.

[0017] Preferably, the identification card is affixed to a treatmentfile containing treatment data for use by the technologist duringtreatment, and the card affixed to the treatment file is caused to beread by the technologist thereby ensuring that the technologist takesthe treatment file into the treatment room.

[0018] In a preferred embodiment, the method further comprisesgenerating an electronic record comprising treatment data associatedwith the treatment to be administered and including said identifyingoptical code, causing the identifying optical code of the electronicrecord to be read by a further optical reader in the treatment room,generating said characteristic audio signal in response to reading ofsaid identifying code of the electronic record, and at least temporarilywithholding treatment if the patient and the technologist do not agreethat any audio signal generated in response to the reading of theidentifying code of the electronic record is the characteristic audiosignal assigned to the patient. Advantageously, the optical readers arecaused to read the respective optical codes of the card and theelectronic record at closely spaced times. Advantageously, therespective optical codes are caused to be read by differenttechnologists. In an advantageous embodiment, the optical readers arelocated on opposite walls of the treatment room. Preferably, the opticalreaders are each a part of respective verification stations located atdifferent locations inside of the treatment room and the storedidentifying code is stored at a verification workstation located outsideof the treatment room and linked to the respective verificationstations.

[0019] More generally, where there is only one optical reader inside thetreatment room, the optical reader is preferably part of a firstverification station located inside of the treatment room and the storedidentifying code is stored at a verification workstation located outsideof the treatment room and linked to the verification station inside thetreatment room.

[0020] In accordance with a further aspect of the invention whichcombines some of the features discussed above, a method is provided foridentification, and verification of the identification, of a patientundergoing radiation treatment by a radiation source administered by atreatment technologist in a treatment room, the method comprising:

[0021] providing a treatment file for the patient to be treatedcontaining a prescribed treatment regimen for the patient;

[0022] providing an identifying card affixed to the treatment file andincluding a photograph of the patient together with an identifyingoptical code capable of being read by an optical reader located withinthe treatment room;

[0023] causing the identifying card of the treatment file to be read bythe optical reader in the treatment room;

[0024] generating a characteristic audio signal known to the patient andthe treatment technologist in response to the reading of the identifyingcard when there is a match between the identifying optical code and astored identifying code for the patient; and

[0025] providing for checking of the treatment file by the technologistif the patient and technologist do not agree that the audio signalgenerated is the characteristic audio signal assigned to the patient.

[0026] As with the method above, the method of this aspect of theinvention preferably comprises generating an electronic recordcomprising treatment data associated with the treatment to beadministered and including said identifying optical code, causing theidentifying optical code of the electronic record to be read by afurther optical reader in the treatment room, generating saidcharacteristic audio signal in response to reading of said identifyingcode of the electronic record, and checking the treatment file and atleast temporarily withholding treatment by the technologist if thepatient and the technologist do not agree that any audio signalgenerated in response to said reading of the identifying code of theelectronic record is the characteristic audio signal assigned to thepatient. As above, the optical readers are preferably caused to read therespective optical codes of the card and the electronic record atclosely spaced times, and, in an advantageous implementation, are causedto be read by different technologists.

[0027] As discussed in connection with the first aspect of theinvention, the optical readers are preferably located on opposite wallsof the treatment room. More generally, the optical readers are each apart of respective verification stations located at different locationsinside of the treatment room and, advantageously, the stored identifyingcode is stored at a verification workstation located outside of thetreatment room and linked to the respective verification stations.

[0028] In accordance with yet another aspect of the invention, a recordand verify method for use with a radiation therapy system including,located in a treatment room, a radiation treatment device for providingradiation treatment and a treatment monitor for monitoring the treatmentprovided by the treatment device, the method comprising:

[0029] using a patient chart for a patient to be treated to entertreatment data into the treatment monitor;

[0030] retrieving stored treatment data for use at a verificationmonitor;

[0031] sending the entered treatment data to the verification monitorfor comparison with the stored treatment data;

[0032] comparing each data entry of the entered treatment data with acorresponding stored data point of the stored treatment data;

[0033] using the verification monitor to output an identifier for eachdata entry which, based on said comparison, is outside of predeterminedtolerances;

[0034] correcting, as necessary, the data entered into the treatmentmonitor based on the output received from said verification monitor toproduce corrected treatment data;

[0035] generating an electronic record of the corrected treatment data;

[0036] using a high speed printer to print the prescribed treatment dataon a paper verification sheet;

[0037] cross-checking the corrected treatment data with previoustreatment data;

[0038] when the printed paper verification sheet is checked anddetermined to be accurate, using the radiation treatment device intreating the patient so as to generate actual core treatment data;

[0039] printing said actual treatment data on the verification sheet toproduce an updated verification sheet;

[0040] after completion of a final treatment field of the radiationtreatment, reviewing and signing off on the updated verification sheet;

[0041] manually entering the actual data obtained from the treatmentmonitor into the patient's chart and reviewing and signing off on themanual entry of the actual data on the patient's chart; and

[0042] checking the core treatment data on the printed hard copy againstthe actual treatment data entered into the patient's chart and, if thereis agreement, signing off on the patient's chart and the paperverification sheet.

[0043] Preferably, first and second radiation technologists carry outthe method, and the first therapist is responsible for steps (a), (c),(f), (j) and (m) and the second therapist is responsible for steps (a),(b), (d), (e), (g), (h), (i), (k), (l) and (n). Advantageously, thefirst therapist also reviews and signs off on the paper verificationsheet upon completion of the method.

[0044] In accordance with still a further aspect of the invention, atreatment verification method is provided for use with a radiationtherapy system including a radiation treatment device for providingradiation treatment, the method comprising:

[0045] providing automated and manual set up options for setting oftreatment field values for the radiation treatment device wherein, inthe automated option, treatment field values are automatically enteredas received from a computer at a verification station and wherein, inthe manual option, the treatment field values are entered by atechnologist at a radiation treatment device workstation;

[0046] setting different predetermined tolerances based on whether thetreatment field values are to be entered in an automated manner by thecomputer in accordance with said automated option or are to be enteredmanually by the technologist in accordance with said manual option;

[0047] selecting between said options and proceeding with the selectedoption;

[0048] comparing each data entry for the entered treatment field valueswith a corresponding stored data point of stored treatment field values;and

[0049] using the verification monitor to output an identifier for eachdata entry which, based on said comparison, is outside of thepredetermined tolerances for the option selected.

[0050] In accordance with yet another aspect of the invention, averification system is provided for use in verification of the identityof a patient about to undergo radiation treatment administered to thepatient by radiation source in a treatment room under the control of atleast one treatment therapist and monitored by a treatment monitorlocated in the treatment room, said system comprising:

[0051] a verification workstation, located outside of the treatmentroom, including means for storing a patient identifying code for thepatient; and

[0052] at least one verification station linked to said verificationworkstation and located within the treatment room at spaced locations onopposite sides of the radiation source, said at least one verificationstation including an optical reader and means for generating an audibleoutput assigned to the patient, responsive to said optical readerreading a patient identifying code assigned to the patient that matchesthe patient identifying code stored at the verification workstation.

[0053] Preferably, first and second verification stations are providedwhich are located within the treatment room at spaced locations onopposite sides of the radiation source.

[0054] In accordance with a further aspect of the invention, a method isprovided for verification of the identity of a patient, the methodcomprising: scanning a patient identifier which identifies the patientto be treated; and generating a characteristic audio signal, previouslyassigned to the patient, in response to the scanning of the patientidentifier when there is a match between the scanned patient identifierand a stored identifier for the patient.

[0055] Preferably, the audio signal is known to at least one of (i) thepatient and (ii) an authorized caregiver for the patient.

[0056] In one implementation wherein the patient is undergoing medicaltreatment, the method further comprises at least temporarily withholdingtreatment of the patient if any audio signal generated in response tothe scanning of the patient identifier is not the characteristic audiosignal assigned to the patient.

[0057] In an implementation wherein the patient is a newborn baby, thescanning is carried out to ascertain whether the newborn may properly beremoved from its current location. Advantageously, an approved caregiverfor the baby is assigned a badge including an identifier and the badgemust also be scanned by the caregiver before the baby can properly beremoved by the caregiver from said current location. Preferably, thepatient identifier is also carried by a name card on the bassinet forthe baby. Advantageously, the patient identifier is also carried by anidentification band worn by the baby.

[0058] In a beneficial implementation of the invention, at least onefurther identifier, in addition to said patient identifier, is scannedfor a match and said characteristic audio signal is generated only aftera match is found in each instance that an identifier is scanned.Preferably, the characteristic audio signal is generated only when amatch is found in each instance and only when the matches occur in apredetermined sequence.

[0059] According to a further aspect of the invention, in addition tosaid scanning of the patient identifier, a caregiver identifier isscanned to determine whether the caregiver identifier is that of anauthorized caregiver for the patient and a check sheet identifier isscanned to determine whether the check sheet is that of the patient, andthe characteristic audio signal is generated only after a match isprovided in every instance. Advantageously, the characteristic audiosignal is generated only when the identifiers are scanned in apredetermined sequence. Preferably, a medication identifier associatedwith a medication about to be given to the patient is also scanned todetermine whether the medication is that intended for the patient and afurther, matching characteristic audio signal is generated when there isa match.

[0060] According to another embodiment of this aspect of the invention,the patient identifier is carried by a medication container formedication for the patient. Preferably, the patient identifier is alsocarried by a medication chart on which the physician first writes anorder for the medication and both the medication container and themediation chart are scanned to determine whether said characteristicaudio signal is generated in response thereto.

[0061] In accordance with yet another embodiment of this aspect of theinvention, scanning takes place in a patient dwelling and the patientidentifier is carried by a container for a medication which is to betaken by the patient and which is prepared by a pharmacy.Advantageously, a prescription for the medication, including the name ofthe patient, is initially written by a physician for the patient, theprescription is received by the pharmacy, and the pharmacy determinesthe corresponding scannable patient identifier assigned to the patientand dispenses the medication in said container carrying said patientidentifier.

[0062] According to a further embodiment of this aspect of theinvention, scanning of said patient identifier comprises scanning of amedical device for delivering a medication to the patient. In oneimportant implementation, the medical device comprises a syringe or asimilar medication infusion device.

[0063] In accordance with still another embodiment of this aspect of theinvention, the patient identifier is carried by a label produced by thecaregiver. Preferably, the caregiver initially dispenses a plurality ofidentical patient identifier carrying labels at the same time. In apreferred implementation, the method is used in chemotherapy treatmentof the patient and said labels are applied to container for all drugsused in the chemotherapy treatment, to all syringes used in thechemotherapy treatment and to at least one patient identificationmember.

[0064] Preferably, said scanning of patient identifier comprisesscanning of a patient identifying member selected from the groupconsisting of a patient photograph, a patient treatment chart, a patientidentification card and an identification band worn by the patient. Inan advantageous application, at least two of the patient identifiers ofsaid group are separately scanned.

[0065] Preferably, said scanning is carried out using a scanning deviceselected from the group consisting of a coded marking scanner, a retinalscanner, a fingerprint scanner, an iris scanner and a scanner for asubcutaneous microchip. In a preferred embodiment, said patientidentifier comprises a barcode and scanning of said barcode is carriedout using a coded marking scanner comprising a barcode reader.

[0066] Advantageously, said characteristic audio signal comprises anon-verbal sound pattern. Preferably, the non-verbal sound patterncomprises a three tone chord. In an advantageous implementation, theduration of said chord is about 2 to 3 seconds.

[0067] In another important implementation, the chord is generated attwo different times, in close sequence, from two spaced locations andthe duration of said chord is about ½ to 2 seconds.

[0068] In accordance with another embodiment of this aspect of theinvention, scanning of the patient identifier comprises scanning twodifferent identification members carrying the patient identifier andresults in the generation of two separate matching characteristic audiosignals at two different spaced apart locations in a treatment room whenthe patient identifiers carried by the two members match said storedpatient identifier. Preferably, the two patient identifiers are scannedby two different separate scanning devices spaced apart in the treatmentroom.

[0069] According to yet another aspect of the invention, a method isprovided for verification of the identity of a patient undergoingtreatment administered by a medical treatment practitioner in atreatment room, the method comprising: providing an identifying elementfor the patient including a patient identifier capable of being read bya reader device located within the treatment room; causing the patientidentifier to be read by said reader device in the treatment room;generating a characteristic audio signal, previously assigned to thepatient and known to the patient, in response to the reading of saididentifying element when there is a match between the patient identifierand a stored identifier for the patient; and at least temporarilywithholding treatment of the patient if any audio signal generated inresponse to reading of the patient identifier by the reader device isnot the characteristic audio signal assigned to the patient.

[0070] Preferably, the identifying element comprises an identifyingmember selected form the group consisting of a patient photograph, apatient treatment chart, a patient treatment verification sheet, apatient identification card and an identification band worn by thepatient. Advantageously, the reader device comprises one of a codedmarking reader and a fingerprint scanner.

[0071] In a preferred embodiment of this aspect of the invention, thefirst and second reader devices are provided in the treatment room aspart of a workstation which also includes first and second spaced audiospeakers for generating said characteristic audio signal, and at least atreatment practitioner is required to scan different patient identifyingelements each including said patient identifier at the first and secondreaders, respectively. Advantageously, one of said patient identifyingelements comprises a patient chart including a photograph of thepatient. Alternatively, or in addition, one of said patient identifyingelements comprises a paper patient treatment verification sheet.

[0072] In a further embodiment of this aspect of the invention, twomedical practitioners carry out the treatment and wherein the treatmentthat the patient is to undergo includes an automatic setup portion whichis carried out automatically under computer control and access to theautomatic setup portion is permitted only if both medical practitionersare designated as having automatic setup privilege. According to arelated aspect of this embodiment, the method is used in a controlsystem to control, based on preselected criteria, access to an existingautomatic download treatment system for a radiation treatment devicewhich automatically transfers prestored patient treatment parameters tothe radiation treatment device. Preferably, said criteria includeverification of privileges of the medical practitioners responsive tologging by the practitioners onto the control system by effectingscanning of a patient chart by one of the reader devices.

[0073] According to a further embodiment of this aspect of theinvention, the patient identifier is carried by a container for amedication for the patient and the characteristic audio signal is knownboth by the patient and the medical treatment practitioner so that boththe patient and the practitioner can be assured by hearing thecharacteristic audio signal that the correct medication container hasbeen provided for the patient. Advantageously, the patient identifier isapplied by an in-hospital pharmacy to the medication container andcorresponds to a patient identifier previously assigned to that patientduring pre-treatment processing.

[0074] According to still another aspect of the invention, a patienttreatment check sheet is provided containing at least a first field forentry of at least the name of the patient to be treated and a secondfield including printed patient treatment parameters and blanks to befilled in during the course of treatment of the patient, said checksheet further comprising at least one fixed patient identifier includingcharacteristic coding adapted to be scanned by a scanning device toprovide reading thereof and at least one removable patient identifierincluding said characteristic coding and adapted to be affixed to afurther element to be used in the treatment of the patient.

[0075] Preferably, the further element to which the removable patientidentifier is affixed is the patient identification member selected fromthe group consisting of a patient photograph, a patient chart, a patienttreatment verification sheet, a patient identification card, a patientidentification band and a combination of a patient photograph and apatient chart.

[0076] In accordance with still another aspect of the invention, averification system is provided for use in verification of the identifyof a patient about to undergo medical treatment administered to thepatient in a treatment room under the control of at least one medicalpractitioner, the system comprising: a verification workstationincluding electronic storing means for storing a patient identifierassigned to the patient to be treated; at least one scanning device forscanning a scannable patient identifier which uniquely identifies thepatient to be treated; and means for generating a characteristic audibleoutput assigned to the patient to be treated and unique to the patient,responsive to matching of the patient identifier scanned by saidscanning device and the patient identifier stored by said electronicstoring means at said verification workstation. Preferably, thescannable patient identifier comprises a bar code carried by a treatmentchart for the patient. Advantageously, the system includes first andsecond scanning devices, located at spaced locations within saidtreatment room, for separately scanning scannable patient identifierscarried, respectively, by (i) a treatment chart and (ii) at least oneother element associated with the patient to be treated.

[0077] In accordance with yet another aspect of the invention, a methodis provided for facilitating billing for medical treatment servicesinvolving treatment of a patient wherein a patient treatment chart isused in conjunction with the treatment of the patient, the methodcomprising the steps of: logging onto a computerized billing system whenthe patient treatment chart is located at a predetermined location in atreatment facility; and generating a billing alert in response to saidlogging on step so as to ensure patient treatment provided at saidlocation will be billed out. In one important embodiment, the logging onstep comprises logging on responsive to use of a scanning device locatedat said predetermined location to scan a patient identifier on saidpatient treatment chart.

[0078] Further features and advantages of the present invention will beset forth in, or apparent from, the detailed description of preferredembodiments thereof which follows.

BRIEF DESCRIPTION OF THE DRAWINGS

[0079]FIG. 1 is a block diagram of a record and verify system inaccordance with one preferred embodiment of the invention;

[0080]FIG. 2 is a flow chart of an initial consultation sequenceinvolving the patient to be treated; and

[0081]FIGS. 3A, 3B, 3C and 3D, taken together, are a flow chart of arecord and verify method in accordance with one preferred embodiment ofthe invention;

[0082]FIG. 4 is a block diagram of a further embodiment of theverification system of the invention as employed in a radiation therapysetting;

[0083]FIG. 5 is a block diagram of yet another embodiment of theverification system of the invention as employed in an access controlmode;

[0084]FIG. 6 is a block diagram of a still further embodiment of theverification system of the invention;

[0085]FIG. 7 is a plan view of a check sheet in accordance with afurther aspect of the invention;

[0086]FIG. 8 is a block diagram of a treatment station in accordancewith yet another embodiment of the invention; and

[0087] FIGS. 9(a) to 9(d) are, taken together, a block form flow chartof a chemotherapy treatment method in accordance with an additionalembodiment of the invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0088] Referring to FIG. 1, a block diagram is provided of one preferredembodiment of the overall system. A treatment room 10 includes aconventional linear accelerator 12 which administers the radiationtreatment to the patient and which may be any conventional analog ordigital system. Two laser verification stations 14A and 14B are providedin the treatment room 10 along with a treatment monitor 16. The 4B areidentical and each preferably includes a respective barcode B and aspeaker 17A and 17B placed into a single mountable box preferredembodiment, the verification stations 14A and 14B are treatment room 10from each other, just beyond the isocenter in the direction of the maze,with the linear accelerator 12 being located between the stations 14Aand 14B. Further, the stations 14A and 14B should be situated so that afirst technologist, Technologist A, is able to scan a chart oridentification card or photograph (not shown) at station 14A on the wall(the left wall is viewed in FIG. 1) while a second technologist,Technologist B, is able to scan a patient's paper verification sheet (asreferred to as an electronic sheet, or e-Sheet) at station 14B on theopposite (right) wall. As described below, the e-Sheet is a verificationsheet used by the technologist during treatment which shows scheduledand actual treatments. With this setup, each technologist faces towardsthe gantry of the accelerator 10 and the patient. It is possible to scanthe chart on the right rather than the left wall but the e Sheet wouldthen have to be scanned on the left wall scanner. It is understood thatwhile the terms “technologist” or “therapist” are used throughout, theactions described can be carried out by an qualified person includingqualified doctors, nurses and other hospital personnel and these termsare intended to cover this.

[0089] The treatment monitor 16 is used to display the name of thepatient and the treatment field values, i.e., the actual fields whichare used by the accelerator 10 and which are verified by theverification system. A typical listing of the treatment fields isprovided in Table 1 below. TABLE 1 Treatment Chart Fields andDescriptions Number Description 1 Hospital Reference Number 2 RadiationOncology Number 3 Protocol Number 4 Patient's Date of Birth 5 ReferringDoctor's Name, Address, Phone Number and Identification number 6Patient's Name 7 Patient's Address 8 Patient's Home Phone Number 9Patient's Work Phone Number 10 Patient's Diagnosis 11 Diagnosis ICU-9Code 12 Palliative or Radical 13 Definitive 14 Adjuvant 15 Pre-Op 16Post-Op 17 Chemotherapy 18 Series Number 19 Current Date 20 Site to betreated 21 Field Description 22 Rx Dose 23 Dose per Fraction 24Cumulative Dose 25 Number of Fractions 26 Energy 27 Modify 28 Reassess29 Stop 30 Planned Rest 31 Total Treatments Planned 32 PhysicianSignature 33 Previous Radiation Technologist 34 Consent Signed 35Collimator Size 36 SAD/SSD 37 Gantry Angle 39 Collimator Angle 40Drum/Table Angle 41 Tray/Wedge 42 Monitor Units 43 Comments 44 Port FilmVerifications 45 Inpatient/Outpatient 46 Elapsed day count for number oftreatments (can start at 0) 47 Radiation Treatment Technologist 48Monitor Units 49 Tumor Dose Cumulative dosage 50 Physics

[0090] Located outside of the treatment room in a treatment console area18 is a verification workstation 20 including a verification monitor 22(e.g., a standard twenty-one inch color monitor) and an associatedhigh-speed printer 24 connected to the verification workstation 20. Alsolocated in area 18 is an accelerator workstation 26 including a cardswipe reader 27 and an accelerator monitor 28. The verificationworkstation 20 basically comprises a personal computer (e.g., NT 4.0)with a keyboard and mouse, which are not illustrated, together with abarcode reader which is shown separately at 21 and a mounted card swipereader shown separately at 23. The workstation 20 preferably has aminimum of a 10-Megabyte hard drive and 64 Megabytes of memory.

[0091] As indicated in FIG. 1, the system also includes a fileserver 30for the verification workstation 20 which is normally located in asecured room 32. Preferably, there is a TCP/IP connection from theverification station 20, and the file server 30 has enough memory tosupport at least one verification workstation. The system may alsoinclude further, optional verification workstations 34 for running anadministration function described below.

[0092] For shorthand purposes, the method of the invention will bereferred to hereinbelow as the VEEBAT (Verify Easily ElectronicallyBefore and After Treatment) method or process, and the verificationworkstation 20 will also be referred to as the VEEBAT workstation.Moreover, certain terminology will be used which is explained below andwhich, for the sake of convenience, is capitalized in the descriptionwhich follows and also defined in the glossary set forth below.

[0093] Before consideration of the process in detail, it is noted thatthe VEEBAT process may take various paths based on its configuration.For example, the configuration may be set up for each patient daily, orjust once. The basic configurable parameters are Treatment Fields,technologist, patient and day of the week. Any combination of parametersmay be configured. The VEEBAT verification process may be run at theverification (VEEBAT) workstation 20 in an Auto Setup Mode or ManualSetup Mode. The mode refers to how the Treatment Field Values areentered into the accelerometer (PRIMUS) workstation 26. A Manual Setupwill have the Treatment Field Values manually entered at the acceleratorworkstation 26 and an Auto Setup will have the Field Valuesautomatically downloaded from the VEEBAT workstation 20 whichelectronically sends the treatment parameters automatically to theAccelerator workstation 26. The VEEBAT process may be configured forAuto or Manual Setup based on four parameters: the technologist, thepatient, the current day, and the treatment. The technologist parameterhas highest priority, i.e., if a particular technologist is configuredfor VEEBAT Manual only, then Manual will take precedence over Autosetup.

[0094] It is noted that the process is configured for two laserverification stations 14A and 14B in the treatment room 10 but may beoverridden to operate with one of the laser verification stations if theother laser verification station fails.

[0095] Regarding the VEEBAT workstation 20, the process is configuredwith the single, above-mentioned barcode reader 21 located at the VEEBATworkstation 20 with the VEEBAT Verification Function. The VEEBATworkstation barcode reader 21 functions only to enable access to theapplication, not to perform the “echo function” (bar-coded photo/e-sheetcross check) described below.

[0096] The process is configured to display various reports at VEEBATstartup. The reports are as follows: partial treatment report,cumulative dose reached report, and scheduled patient report. Thereports will be displayed on monitor 22 in a scrolling fashion that canbe controlled by the person viewing the reports. The partial treatmentreport will give a listing of patients who received partial treatmentthe previous day. This report will include the date and the patient'sname. The cumulative dose reached report will list patients who have orwill exceed their prescribed cumulative dose. The patient's cumulativedoses is prescribed by the Radiation Oncologist. The report will includethe date and the patient's name. The scheduled patient report will listall patients who are scheduled for treatment on that date. The reportwill include the patient's name and time of treatment.

[0097] As an initial matter, referring to FIG. 2, a Patient's File iscreated on the patient's initial visit. A Patient's File creationconsists of the initial consultation and, if advised, the patient'sradiation oncology consultation. These steps are indicated in FIG. 2 byblocks 36 and 38. These particular sections of the Patient's Filedetermine if a patient should be treated and, if so, the treatmentstrategy. A patient's initial consultation determines if radiationtherapy is advisable. A radiation secretary creates a Red Folder. Thefolder contains the patient's referral and medical history. If treatmentis advised, a patient is set up for a radiation oncology consultation.Otherwise, the patient's Red Folder will be archived. A radiationoncology consultation determines a patient's prescribed treatment. Thepatient's initial Red Folder is then moved to a White Folder. Thepatient's VEEBAT account is created along with a Treatment Folder. TheWhite Folder is a permanent folder for a patient. It will contain theinitial Red Folder's contents and radiation oncology consultation.

[0098] After completion of a patient's scheduled treatments, alldocuments in the Treatment Folder are moved to the patient's WhiteFolder. The Treatment Folder is used during the patient's treatments.The folder contains a Treatment Chart, e Sheet, patient set-upphotographs and the patient's Polaroid Photo. These items are discussedbelow. The Treatment Folder also contains the dose calculation worksheets and simulation data, consent form and computer isodose plans, aswell as in-vivo dosimetry data. The purpose of using two folders perpatient is to reduce conflicts during treatment caused by situations inwhich radiation treatment technologist (R.T.T.) and nursing personnelsimultaneously require access to the medical record. The White Folderand Treatment Folder are presented to the Radiation Oncologist fortelephone calls, patient encounters, dictation, and the like. TheTreatment Chart contains a patient's original prescription and treatmentschedule signed by the Radiation Oncologist. The chart is used duringtreatment by the Technologist to manually enter Treatment Field Valuesinto the accelerator workstation 26. Typical Treatment Field Values areset forth in Table 2 below. TABLE 2 Number Name 1 Monitor Units 2Jaw/Collimator Size 3 Collimator Angle 4 Gantry Angle 5 Table Drum Angle(optional)

[0099] The e Sheet mentioned above, used during the verification processto store prescribed and actual Treatment field Values. A new TreatmentFolder will receive a blank e Sheet. A barcode is attached to the eSheet. A detailed listing of above. Each Treatment Folder containspatient's set-up photographs to indicate the area for treatment alongwith tattoo markings. Each patient's Polaroid Photo. This photograph orpicture is used during the verification process to help insure theTreatment Folder belongs with the patient being treated. A barcode isattached to the Polaroid Photo.

[0100] The method and system of the invention lends itself well toaccounting and billing tasks. As a first step, the patient's VEEBATAccount is created. The account is used in the verification procedureduring treatments. The account is generated on a VEEBAT verificationworkstation 20 (or one of the optional workstations 34) using the VEEBATAdministration Function. A typical chart with a detailed listing offields and descriptions is provided in Table 3 below. Barcodes on thepatient's e Sheet and Polaroid photo will be associated to the patient'sVEEBAT Account. As described in more detail below, the patient will beassigned a unique audio signal (e.g., a three tone audio signal in theexemplary embodiment under consideration) that will be used for audioverification by each of the patient, Technologist A and Technologist Bin the Treatment Room prior to treatment. TABLE 3 Patient InformationRT#: Patient Name: Date of Birth: Referring MD: (link into UPIN chart)City of Residence: Telephone No (home): Telephone No (work): Diagnosis:{ascii text} ICD 9 Code: (link into ICD 9 chart) Chemotherapy    y/nHormone Therapy    y/n Bar code - Polaroid photo: Bar code - e Sheet:(link to actual treatment delivered)

[0101] A simulation system provides access to a comprehensive library oftreatment strategies, including treatment protocols, simulationchecklists, guides on how to order tests, and test rationale and, asindicated by block 40 in FIG. 2, a simulation work-up can be provided aspart of the initial consultation process.

[0102] Turning now to the actual patient treatment process which is onekey aspect of the present invention, and referring to FIGS. 3A to 3D,the patient arrives for treatment as indicated by block 42 and checks inwith the receptionist. Technologist A obtains the patient's TreatmentFolder, scans the patient's Polaroid Photo at the treatment console orworkstation 20 to initiate VEEBAT Verification Function, and ensures thepatient matches the patient Polaroid Photo, as indicated by block 44. Ifthere is a match, Technologists A and B escort the patient to treatmentroom 10 (block 46). Technologist B obtains the patient's e Sheet fromthe Treatment Folder. Technologist A scans the photo at the barcodereader 15A of the verification station 14 (block 48). If Technologist Ais unable to scan the photo for any reason, a Supervisor will berequested to help resolve the problem. Once the photo has beensuccessfully scanned, the VEEBAT verification workstation 20 willassociate the photo with the patient's VEEBAT Account in the VEEBATDatabase (block 50). If the patient's VEEBAT Account is not found, anAudio Error Signal (“beep”) will be emitted and a Supervisor will berequired to resolve the problem.

[0103] Considering in more detail the steps which take place, afterTechnologists A and B escort the patient into Treatment Room 10, thepatient is correctly positioned on treatment table. Technologist Aproceeds to either laser verification station 14A or 14B. Technologist Bproceeds to other laser verification station. It will be assumed herethat Technologist A is at station 14A and Technologist B is at station14B. Technologist A then scans barcode on the patient's Polaroid Photoat the barcode reader 15A (block 48). The barcode is passed to theVEEBAT Verification Function at the verification workstation 20 toensure the barcode matches the Polaroid Photo bar code that was justscanned outside the treatment room at the verification workstation 20.If valid, the patient's audio signal is emitted at the verificationstation 14A. If the Technologist fails to scan the Patient's PolaroidPhoto at the VEEBAT verification workstation 20, an Audio Error Signalis issued. This will require the Technologist to go back to the VEEBATverification workstation 20 to scan the Patient's Polaroid Photo barcode to initiate the VEEBAT Verification Function. Further, if the barcode scanned at barcode reader 15A of verification workstation 14A is avalid VEEBAT account bar code, but does not match the bar codepreviously scanned at the VEEBAT verification workstation 20, an audioError Signal will be emitted in this case as well and a Supervisor willbe required to resolve the problem. If the patient's e Sheet bar code isscanned first, i.e., if the bar code scanned is the e Sheet bar codeassociated with the current VEEBAT Account, an audio Warning Signal isissued and the system waits for the Patient's Polaroid Photo bar code tobe scanned. If the bar code is not a valid VEEBAT bar code, it will beconsidered to be a read error. The VEEBAT verification workstation willemit an audio Warning Signal and wait for a re-scan. Considering otherpotential failures, if the bar code is found but the patient cannot betreated, an audio Error Signal is issued. Again a Supervisor is requiredto resolve this problem. If the patient's cumulative dose exceeds orwill exceed the patient's prescribed dose, a stop order is issued. Inthis regard, the patient's VEEBAT Account has a stop treatment flag set,which is determined by the Radiation Oncologist.

[0104] The patient name and scheduled Treatment Field Values from theselected VEEBAT Account are displayed on the treatment monitor 16 in alarge font for easy readability. Also, if a port verification film (PVF)is scheduled, a reminder will appear on the treatment room monitor 16 toremind the technologists. Technologists A and B will visually verifythat the name displayed on the monitor matches the patient's name. Ifnot, a Supervisor shall be called to resolve the problem.

[0105] Referring to FIG. 3B, in the next step, Technologist B scans thepatient's e Sheet bar code, as indicated by block 52 at barcode reader15B of verification workstation 14B. The VEEBAT Verification Functionthen verifies that the bar code is assigned to the patient's VEEBATAccount. Verification of the patient chart and e Sheet is then provided.As shown by decision diamond 56, if valid, i.e., if there is a match,the patient's audio signal is emitted. If there is no match, an audioError Signal is emitted and a Supervisor is required to resolve thisproblem (block 58). When the tone is emitted, Technologist A,Technologist B, and the patient all verify that the audio signalsemitted from Verification Stations 14A and 14B are the same. The use ofidentification signals such as unique audio signals is an importantaspect of the invention and, among other advantages, provides a comfortlevel for the patient that is not available with other methods andsystems. If anyone questions the comparison of the audio signals, aSupervisor is required to resolve this issue. This aspect of theinvention, i.e., the use of an audio signal unique to the patient andthe requirement that the patient and the technologist (or technologists)in attendance all verify the signal, is discussed in more detail below.

[0106] Next, as shown by block 60, Technologist A proceeds toaccelerator workstation 26 and Technologist B proceeds to the VEEBATverification workstation 20 to access the VEEBAT Verification Function.Technologist A logs onto the accelerator workstation 26 (block 62) anduses the card swipe reader 27 located on the accelerator workstation 26to register with the Verification Function of the VEEBAT verificationworkstation 20. If Technologist A is unknown or does not have privilegeto apply treatment, then the Verification Function of the verification(VEEBAT) workstation 20 will display a message at the VEEBAT workstationindicating the discrepancy. A Supervisor will be required to resolvethis problem.

[0107] Technologist B logs onto the VEEBAT verification workstation 20by using the card swipe reader 23 located on the VEEBAT verificationworkstation 20 that uses the VEEBAT Verification Function (block 64). IfTechnologist B is unknown or does not have privilege to apply treatment,then the Verification Function will display a message on the VEEBATverification workstation 20 indicating the discrepancy. A Supervisorwill be required to resolve this problem. Technologist B then views thescheduled Treatment Field Values for the patient at the VEEBATworkstation 20 (block 66).

[0108] As indicated by decision diamond 68, and was discussed above, theVEEBAT process can be configured for Manual Setup or Auto Setup. If theformer confirmation is chosen, as indicated by block 70, the steps setforth at the left side of FIG. 3C are taken. Considering these steps,Manual Setup first requires that Technologist A manually enter TreatmentField Values as indicated on the patient's Treatment Chart at theaccelerator workstation 26. The Treatment Field Values are thenautomatically verified at the VEEBAT workstation 20 by the VEEBATVerification Function against the patient's prescribed treatment. Asshown by block 74, Technologist A manually enters Treatment Field Valuesindicated on the patient's Treatment Chart at the acceleratorworkstation 26. Technologist B then places the VEEBAT VerificationFunction in ready-to-receive mode. Technologist B verbally requestsTechnologist A to electronically send the patient's Treatment FieldValues that were manually entered at the accelerator workstation 26 tothe VEEBAT workstation 20 (block 76). The accelerator (PRIMUS)workstation 26 electronically sends the data to the VEEBAT workstation20 when Technologist A presses a designated button (e.g., the “ACCEPT”button) on the accelerator keyboard (block 78). The VEEBAT workstationVerification Function will only receive values from the acceleratorworkstation 26 when the VEEBAT verification workstation is in theready-to-receive mode. At any time, Technologist B has the option tocancel the ready-to-receive mode, thus returning the VEEBAT verificationworkstation 20 to its previous state.

[0109] As indicated by block 80, the VEEBAT Verification Function, afterreceiving the accelerator values that have been entered, will thenverify all patient's Treatment Field Values and confirm that all valuesare within predetermined tolerances. If any Treatment Field Values arenot within the predetermined tolerances, the VEEBAT verificationworkstation will give an audio Warning Signal (“beep”) and display anasterisk beside each field that is not within the predeterminedtolerance. If all fields are within predetermined tolerance (i.e., whenthe output of decision diamond 82 is “yes”), the method or procedurecontinues as described below.

[0110] As indicated by decision diamond 82, if accelerator manual valuesare incorrect, Technologist B advises Technologist A to reenter anyTreatment Field that was flagged at the VEEBAT workstation with anasterisk (block 84). The processing is then repeated. If Technologist Aintentionally enters in a value that is not consistent with thepredetermined tolerance for any of patient's Treatment Fields, aSupervisor override is required.

[0111] Referring to the right side of FIG. 3C, the Auto Setupconfiguration electronically sends values from the patient's VEEBATAccount through the VEEBAT verification workstation 20 to theAccelerator workstation 26. In this regard, in the specificimplementation under consideration, Technologist A places theaccelerator workstation in a ready-to-receive mode by depressing aspecific key (e.g., the F5 key) on the accelerator keyboard (not shown).Technologist A verbally requests Technologist B to electronically sendthe patient's Treatment Field Values(block 86). Technologist B, bydepressing a download key, sends the requested patient's Treatment FieldValues to the accelerator workstation 26.

[0112] It is noted that in accordance with a further aspect of theinvention different tolerances are provided for Manual Setup and AutoSetup. In Auto Setup, relatively tight tolerances are provided so that,for example, the gantry angle tolerance may be ±1°. Although theautomated operation has its advantages, it is important in somecircumstances to provide a manual approach wherein the RTT manually setsthe Treatment Field Values. Such a manual approach can be customized tothe requirements of the patient over time and, in this regard, theTreatment Field Values may be changed over the course of treatmentduring the day. As a consequence, the tolerances set here should berelatively wider to accommodate the manual approach and, for example,the gantry angle tolerance may set at ±5°. Thus the VEEBAT functionprovides a different set of tolerances for Manual Setup versus AutoSetup.

[0113] Referring to FIG. 3D, which depicts the remainder of the methodor procedure, which is common to both the Manual Setup and Auto Setup,Technologist B requests the VEEBAT verification workstation 20 to printa treatment entry on the patient's e Sheet at printer 24 (block 86),i.e., the date, energy, MU and wedge (i.e., the number of the wedgeused, if any) for each prescribed/scheduled Treatment Field of thecurrent treatment session. This occurs before the first treatment fieldfor this treatment session. If this is not the patient's initialtreatment session, the technologist will compare the printed values onthe e Sheet to the previous treatment values (i.e. the line above on thechart). If the verification fails, a Supervisor is informed of anydiscrepancies.

[0114] As indicated by block 88, Technologist B next gives theAccelerator workstation 26 permission to treat the patient via theVEEBAT verification workstation 20 and verbally informs Technologist Ato proceed with treatment. If, during treatment, the accelerator 12fails to give a complete treatment due to mechanical failure ortechnologist intervention, Technologist A may “fix” the problem andresume treatment until treatment is complete. However, if Technologist Ais unable to complete treatment due to equipment failure or humandecision, a Supervisor should, at a later time but prior to nexttreatment, manually write in the make-up dosage in the right margin ofthe Treatment Chart and override the patient's VEEBAT TreatmentSchedule.

[0115] Next, as indicated by block 90, the actual Treatment Field Valuesare sent to the VEEBAT verification workstation 20 from acceleratorworkstation 26. The VEEBAT Verification Function updates the screen withactual treatment dose delivered and saves the values to the VEEBATfileserver 30. If this is not the last treatment beam of the session,the technologists return to the treatment room and set up the patientfor the next treatment field. If this is the last treatment, as shown byblock 92, Technologist B submits the e Sheet to print the actualmonitoring units (MU) on the same row of the e Sheet where theprescribed/scheduled Treatment Field Values are printed on the e Sheetin step 86 above. Thus, in a preferred embodiment, the e Sheet willinclude columns of entry spaces for the date, energy, wedge and MU, andfor initialing by the Technologist or therapist. Such an e Sheet hasimportant advantages because of its simplicity. An asterisk will beprinted beside each Treatment Field that received a MU value outside thepredetermined tolerance range. If one or more Treatment Field MUs wereprinted with asterisks, an asterisk will also be printed in the farright-hand column for the day's treatment. This asterisk indicates anydiscrepancies to the reviewing Physicist. Technologist B should initialthe e Sheet at the appropriate session entry space and hand it totechnologist A to initial and return to the patient's Treatment Folder(block 92). Technologist A enters the actual Treatment Field Values asshown on the accelerator workstation screen on the Patient's TreatmentChart (block 94). Technologist A then initials the Patient's TreatmentChart at the appropriate session line and hands it to Technologist B.Technologist B initials the Patient's Treatment Chart at the appropriatesession line and returns it to the Patient's Treatment Folder (block96).

[0116] Referring to block 98, at the end of the day, various reports canbe requested. The reports are generated at a VEEBAT verificationworkstation 20 using the VEEBAT Administration Function. These reportscan include a report of patients who received partial treatment. Thisreport will list each patient that received a smaller dose for that daythan was prescribed for that day. This report shall contain patientnames and RT numbers.

[0117] The reports may also include a list of scheduled patients whowere not treated. Such a report will list each patient who was scheduledfor treatment that day but did not receive treatment that day for anyreason. This report shall also contain the Patient names and RT numbers.

[0118] Statistics can also be output for the following treatment types:electron, photon, simple, intermediate and/or complex.

[0119] A billing summary can also be produced. This report will listcharge codes for each patient treatment as well as patient's name, andconcurrent chemotherapy or hormone treatments, if any.

[0120] A report can be generated on any information maintained in theVEEBAT database which is located on Fileserver 30.

[0121] Considering in more detail the use of a photograph of the patientin generating distinctive audio output, in a preferred embodiment, aphotograph of the face of the patient with an identifying barcode istaped or otherwise affixed to the inside front jacket of the TreatmentChart, although the photograph and bar code can take other forms and beprinted or mounted on other media. When the chart photograph, withbarcode, is scanned by the barcode reader of the corresponding laserverification station in question (station 14A in the example above), asuitable audio output which is uniquely associated with, i.e., specificto, the particular patient is emitted by the speaker (not shown) of thestation. Conventional methods are available to generate a specific audiooutput in response to a corresponding triggering input, includingcomputer generation of sounds or tones. As described above, verificationstation 14B is used to scan the patient's e sheet. In the specificexemplary embodiment under consideration, the audio output is an audiosignal which takes about one second to complete. Of course, while asoothing tone sequence is preferred and has important advantages, otheraudio outputs can be used including a recording of the patient's name.

[0122] In an exemplary embodiment wherein three sequence of tonescomprising the three tone chord is determined at simulation by thepatient's RT number. For example, departments with different lengths ofpatient identifying numbers can adjust with a different range ofoctaves. Four digit departments can use a different octave for the firstdigit Five digit departments can use a different octave for the firstand second digit. Digits which begin with eight or nine can use sharpsor flats as the first digit.

[0123] As indicated above, in the specific application underconsideration, the second therapist, Therapist B, scans the patient's eSheet at barcode reader 15B at laser verification station 14B locatedinside the treatment room on the opposite wall from station 14A, and aconfirmatory audio signal emitted from the speaker 17B at station 14B isreassuring the staff that the Treatment Chart's face photo matches the eSheet. This creates an opportunity to detect whether another patient's eSheet has been inadvertently placed in the Treatment Chart. The audiosignal emitted at station 14A obtained by scanning the patient'sTreatment Chart should match precisely the audio signal emitted from thespeaker 17B at station 14B. This process of scanning the TreatmentChart, producing a patient specific audio signal and then confirming theaudio signal by scanning the e Sheet and producing the audio signalagain is referred to herein as “echoing.” Echoing is performed mostefficiently when the e Sheet is scanned almost immediately after theTreatment Chart is scanned and thus generates its audio signal.

[0124] The sequence of Treatment Chart audio signal activation, followedby e Sheet tone activation, confirms that the Treatment Chart photobarcode is the same as the e Sheet barcode. If the wrong Treatment Chartis selected, the patient should notice a non-familiar audio signal,providing a self-managing dimension to the VEEBAT process. Patientsoften report to their radiation oncology caregivers that they count theseconds of treatment or that they occasionally report perceived changesin the sound of the accelerator as it delivers the radiation treatment.The confirmatory audio signal should reassure anxious patients, whileallowing an opportunity for wrong audio signal to be noticed by apatient. This provides an added incentive for the staff to select thecorrect Treatment Chart since the patient also participates in the crosschecking process.

[0125] In accordance with a further feature of this aspect of theinvention, subsequent fields will be confirmed by a repeat of the lasttone and the next tone of the second field, the last tone and the twonext tones for the third field, and the last tone and three consecutivetones for the fourth field. Variations of this tone feedback processcould be used for three dimensional conformal therapy. Certainly, manypatients are already primed for audible feedback and the use of audioconfirmation should be of help to patients as well as the staff. Theforegoing sequence of barcode scanning brings up the patient's VEEBATparameters which may then be downloaded for Auto Setup or Manual Setup,followed by verification before and after treatment as described above.This verification process provides a number of important advantageswhich will now be described.

[0126] First, two therapists are encouraged to enter the room with thepatient and the Treatment Chart, maximizing the opportunity forsatisfactory visual crosscheck. Both therapists are encouraged to enterthe room because efficiency inside the room will be rewarded by bringingup the VEEBAT parameters more rapidly, either for Manual Setupverification or Auto Setup. As indicated previously, two therapists arenot required to enter the room but if only one therapist enters theroom, she or he will still have to bring the Treatment Chart so that nocharts will be left on the counter outside the treatment room. Moreover,the lone therapist will still have to set up the patient properly, thenactivate the VEEBAT queue with the e Sheet at the right wall, i.e., atstation 14B, as viewed in FIG. 1 .

[0127] Further, with two therapists Therapist A must be with the patientat the left side of Accelerator 12 before the audio signal can begenerated. The Treatment Monitor 16 and the VEEBAT monitor 22 willdisplay simplified patient parameters only after the e Sheet is properlyscanned and the second audio signal is generated at station 14B.Typically, the simplified parameters are defined as a field number,i.e., 1) AP pelvis/prostate, 2) R lat pelvis/prostate, 3) PApelvis/prostate, and 4) L lat. If Auto Setup has been approved by theRadiation Oncologist for the treatment of the patient, then treatmentmonitor 16 (in treatment room 10), and VEEBAT monitor 22 (on thetreatment counter) will display the simplified patient parameters with,e.g., red letters. If the patient is being treated using Manual Setup,then the corresponding screens will display the simplified patientparameters with different, e.g., white, letters.

[0128] Because the display will also appear on VEEBAT monitor 22 at thetreatment counter in area 18 which is not in treatment room 10, thisprovides advanced queuing for treatment, thereby minimizing delaysoutside the room due to delays in calling up the parameters after thepatient's alignment has been visually cross-checked.

[0129] In an advantageous implementation, patients are assigned a new RTnumber and bar code for each course of radiation therapy. In anadvantageous implementation, if a patient returns to the radiationoncology department in the future, e.g., for a second course ofradiation therapy several years in the future, a fourth note will beadded before the three-tone chord assigned for the current year,creating a new four-note chord. This serves as an audible reminder tothe staff that the patient has had a previous course of therapy, andthat they should watch our for possible overlap of the current fieldwith the prior fields. A third course of therapy will generate a fifthnote. In other words, in this implementation, there will be two tones,followed by a pause, followed by the three-tone chord for the currentcourse of radiation treatment. It is more difficult to audiblydiscriminate longer sequences of tones, and this approach takesadvantage of this. The greater the number of prior courses of radiationthe patient has had in prior years, the more difficult it is for thetherapist to feel comfortable with alpha-beta confirmations, and themore motivated he or she will be to go back to the records to verifylack of overlap with the current fields.

[0130] One very important advantage of the verification method andsystem of the invention is that its primary method of supplementalcommunication is audio, thereby eliminating the use of additional visualdistractions that might divert the attention away of the therapists fromthe patient's Treatment Chart and actual treatment setup and visualcross-check. This approach also provides for more efficient queuing ofthe server verification data to the monitor outside the treatment room,so as to provide time for therapists to perform an officialverification, followed by treatment, immediately upon reaching thetreatment counter or console. Overall, the invention should maketreatments faster and more accurate than with existing record and verifysystems, because the invention enhances and verifies efficient manualprocess without altering therapist behavior. GLOSSARY Accelerator Theactual accelerator located in the treatment room. Accelerator System TheAccelerator Workstation and the Accelerator. Accelerator Part of theAccelerator System, Consists of Workstation monitor, special keyboard,and computer. Location is outside the room of the Accelerator. AutoSetup The Accelerator System receives its Treatment Field Values fromthe Auto Download Verification Function Bar Code A label on the PolaroidPhoto and e Sheet used to identify electronically the patients VEEBATAccount. Card Swipe Device used to identify user by badge numberCumulative Dose Total Radiation received e Sheet Verification sheet usedby Technologist during treatment showing scheduled and actual treatmentsError Signal Audio tone emitted from VEEBAT Workstation when an errorrequiring a Supervisor is required. ICD-9 Codes Used to categorizepatients cancer location Laser Verification A verification stationlocated in the treatment Station A room. Consist of a bar code readerand a speaker. Used by Technologist A to read a patients bar codedPatients Chart. Laser Verification A verification station located in thetreatment Station B room consisting of a bar code reader and a speaker.Used by Technologist A in reading a patient's bar coded Patients Chart.Manual Setup The Accelerator System receives its Treatment Field Valuesfrom the Accelerator Workstation MU The length of a treatment (MonitorUnits). Patients File Patients Treatment Chart, e Sheet, and PolaroidPhoto PC Personal Computer. PVF Port Verification Film Polaroid PhotoPicture of Patient Radiation Oncologist Physician Red Folder A patientsfolder until treatment is determined RT Radiation Oncology Number. RTTRadiation Therapy Technologist RTT Radiation Therapy Technologist(Technologist) Setup Room Room where Technologist A and B run theAccelerator and VEEBAT Systems Radiation Oncology Work done with thesimulator to determine a Consultation patients treatment SupervisorSenior Radiation Technologist TCP/IP Network communication protocol.Technologist A Technologist responsible for VEEBAT Verification duringtreatment. Technologist B Technologist responsible for AcceleratorWorkstation during treatment. Total Dose Total prescribed dose TreatmentField Actual fields used by the Accelerator and Values verified by theAuto Download Verification Function. See Appendix A for list. TreatmentFolder Folder used by Technologist during treatment Treatment Monitor Amonitor located in the treatment room used to show a patients name andTreatment Field Values VEEBAT Account Electronic data entered via VEEBATWorkstation with VEEBAT Administration Function. VEEBAT A programrunning on a VEEBAT Workstation. Administration The program is used tocreate and access Function patients VEEBAT accounts stored on the VEEBATfileserver. The program also provide various report generation functionsand administrative functions (i.e. System Backup) VEEBAT Fileserver Aworkstation with houses the VEEBAT Database. VEEBAT Process VerifyEasily Electronic Before and After Treatment Process VEEBAT System Theactual components used to implement the VEEBAT Process VEEBATVerification A program running on a VEEBAT Workstation. Function Theprogram is used to provide a verification before and after treatmentVEEBAT Workstation A workstation with monitor, keyboard, mouse, CPU, barcode reader, and card swipe. The workstation provides the VEEBATAdministration and/or Verification Function. Warning Signal Audio toneemitted from VEEBAT Workstation when an error occurred but does notrequire a Supervisor. White Folder A patients permanent folder duringand after treatment

[0131] Referring to FIG. 4, a block diagram is provided of a furtherpreferred embodiment of the overall system. The system is similar tothat of FIG. 1 but incorporates a number of differences as discussedhereinafter or as will become apparent. A treatment room 110 includes aconventional linear accelerator 112 which administers the radiationtreatment to the patient and which can be any conventional analog ordigital system. A single verification workstation is provided in thetreatment room 110 which is comprised of the following components whichare not specifically illustrated: a computer processor, a keyboard, anda mouse. The workstation 114 also includes a monitor 116, a singlemagnetic code reader 118 located at the verification workstation 114,and two sets of barcode readers 120A, 120B and speakers 122A, 122B. In apreferred implementation of this embodiment, each set of barcode readerpairs 120A, 120B and speaker pairs 122A, 122B are located in thetreatment room 110 across from each other. In other words, barcodereader 120A and associated speaker 112A are located on one side of theroom and barcode reader 120B and associated speaker 122B are located onthe other side of the room. An optional fileserver 124 is located in aremote location so as to enable the use of a client-server based systemand permitting an optional verification workstation 126 to be located ina treatment console area 128 or other areas or remote rooms 130 asindicated at 132. This enables carrying out of system administrationactivities, initial patient registration, and report generation but nottreatment activities. In the treatment console area 128 are located aconventional accelerator workstation 134 and an associated monitor 136.

[0132] With the setup illustrated in FIG. 4, the first technologist,Technologist A, is able to swipe his or her unique ID badge at themagnetic code reader 118 located at the verification workstation 114inside the treatment room 110, registering the technologist as the“treatment” technologist. The second technologist, Technologist B, isthen able to swipe his or her unique ID badge at the magnetic codereader 118, registering the technologist as the “verification”technologist. Technologist A is then able to scan the patient photographat the barcode reader 120B located near the verification workstation114. At this time, the system will determine if the “Auto Setup”treatment described above is permitted. Access to the Auto Setupfeatures of the workstation 114 is only allowed if both technologistshave privilege for Auto Setup and if Auto Setup is approved for thetreatment of the patient. This is determined by the Radiation Oncologistand configured during initial patient registration. Next, the patient isset up at the linear accelerator 112 and oriented properly on thetreatment table. Technologist A then scans the patient photograph asecond time at the barcode reader 120B, thereby generating the patientunique audio signal. Technologist B then scans the patient's paperverification sheet (referred to above as the electronic sheet, ore-sheet or check sheet) at the opposite barcode reader 120A, therebyagain generating the patient unique audio signal.

[0133] The verification process described above in connection with FIG.4 provides a number of important advantages. First, the therapist(s) arerequired to enter the treatment room with the patient since the onlyverification workstation permitting treatment set-up, viz., verificationworkstation 114, is located inside the patient treatment room 110.Having both therapists inside the room maximizes the opportunity forsatisfactory visual crosschecks. Second, the patient's chart andphotograph must be taken into the room since these items are required togain access to the verification workstation. Together, these two itemsare the key to establishing a “default to a safe mode of operation”process or situation. In other words, with the patient's chart in thetherapist's hands and the therapist(s) inside the treatment room duringthe critical patient set-up period, the therapist(s) are given theopportunity to detect their own errors.

[0134] In another preferred embodiment, shown in FIG. 5, the system ofthe invention is utilized with an existing auto-download treatmentsystem (such as LANTIS, IMPAC, or VARIS) in a standard treatmentfacility. The system of the present invention is indicated in FIG. 2 asthe VEEBAAT system, which as indicated above, is the trademark used toidentify the system, and includes a computer 140, a monitor 142, akeyboard 144 and a mouse 146. The conventional system includes, in thetreatment room 148, a PRIMUS accelerator 150, a LANTIS auto-downloadunit 181 including a monitor 142, keyboard 154, mouse 156, and LANTISKVM (keyboard, video, mouse) receiver 158. The latter is connected to aLANTIS KVM splitter 160 which is located in an area 162 outside oftreatment room 110 which is, in turn, connected to a LANTIS monitor 164and to a LANTIS computer 166 connected to a PRIMUS computer 168 whichcontrols accelerator 150. The existing auto-download treatment systemcommunicates with the accelerator's computer to automatically passpatient treatment parameters prestored in a database to the accelerator150 in the place of requiring these treatments to be entered manually bythe technologist.

[0135] In the configuration shown in FIG. 5, the system of the inventioncan be utilized to prevent access to the auto-download system unless aparticular set of criteria are met. The criteria are as follows: bothtechnologists must log into the VEEBAAT system, both technologists musthave permission to utilize the auto-download system (and as indicatedabove, this is a configurable item defined within the VEEBAAT program),the ICD-9 code (a code which defines the type/location of the cancer)must be configured to allow auto-download (also a configurable itemdefined within the VEEBAAT program), and the patient must be configuredto allow auto-download (another configurable item with the VEEBAATprogram). If any of the criteria is not met, access to the existingauto-download system is not allowed. All of the configuration items arecontrolled within the control system of the invention and can be alteredby an administrator who has been given permission to access/alter thesesettings. The system of the invention also includes a built-in accesslevel security system which enables tailoring authority or permissionsfor given users of the system. By controlling these configuration items,the treatment facility may limit the use of the auto-download system toindividual technologists, individual ICD-9 codes, individual patients,or any combination of the three, as desired.

[0136] Access to the auto-download system is controlled by an electronicKVM (Keyboard, Video, Mouse) switch 170 and controlled by computer 140.The KVM switch 170 is located between the auto-download computer 140 andthe auto-download unit 151 comprised of monitor 152, keyboard 154 andmouse 156. The computer 140 of the system of the invention controls theswitch 170 via an RS-232 serial connection and enables/disables theauto-download system (keyboard/video/mouse) unit 151. The auto-downloadsystem is connected to Port A of the switch 170. Port B is leftunconnected. When the switch 170 is positioned to Port A, access to theauto-download system is permitted. When the switch is positioned to PortB, access to the auto-download system is prohibited.

[0137] The system of the invention allows access to the auto-downloadsystem when all the required criteria have been met. If the criteria arenot met, access to the auto-download system is prevented, therebyforcing the technologists to treat the patient in manual mode and enterthe patient treatment data manually into the computer 168 associatedwith the accelerator 150. If the criteria are met, access to theauto-download system is permitted and the technologists can then loadthe patient treatment information from the database and auto-download itto the accelerator computer 168. With this configuration, theauto-download system (i.e., the monitor 152, keyboard 156, and mouse156) is located inside the treatment room alongside the VEEBAAT system(computer 140 and monitor 142, keyboard 144 and mouse 146). Thisconfiguration forces the technologists to enter the treatment room withthe patient chart. The technologists are therefore forced into a processwhich “defaults to a safe mode of operation” should a system failureoccur, since the patient chart is required to gain access into theVEEBAAT system and VEEBMT access is required to gain access to theauto-download system.

[0138] In accordance with yet another embodiment of the invention, theinvention is used to assist verification of medications to be taken by apatient in a hospital or like patient treatment setting. In thisembodiment, a laser barcode scanner or like detector or reader, and anassociated speaker, corresponding to those described in connection withprevious embodiments, is located near or at the bedside of a patient andpreferably mounted on the wall. In addition, software is used whichgenerally corresponds to that described above but which is adapted, andsimplified, to carry the functions described.

[0139] In use of the system of this embodiment, the physician firstwrites an order for medication in the patient's chart. The pharmacywithin the hospital receives the order for the particular patient anddispenses medication assigned to, i.e., in association with, a patientspecific bar code assigned to that patient. In other words, themedication is dispensed in a packet, bottle, carrier, container or thelike, with the patient specific barcode thereon.

[0140] Next, the bar coded medication is picked up by or delivered to anurse or other authorized medical practitioner who brings the medicationto the patient's beside along with the patient's medication sheet.

[0141] In the next step, the nurse scans his or her badge or activateshis or her user identifier. Then the nurse provides that the medicationsheet is scanned by the scanner or reader, followed by the patient'swristband, and a patient specific tone sequence is emitted based on thebarcode on the sheet. The nurse then provides scanning of the medicationcontainer or carrier (for example, an I.V. or bar-coded pill dish) so asto generate a matching tone sequence so that the nurse knows that themedication container barcode and medication sheet barcode match. Asindicated above, the patient will learn to recognize his or her patientspecific tone sequence, i.e., recognize a particular sequence as beinguniquely his or hers. Moreover, the nurse will be aware that thepatients will learn their specific tone sequence, and thus there is anincreased incentive for the nurse to verify that the medication iscorrect.

[0142] When the tone sequence is matched and identified, the patienttakes the correct medicine. The system also records and verifies thatthe correct medicine was given to the patient.

[0143] In a further implementation of this particular embodiment, thesystem is used to assist in identifying authorized personnel assigned toa neonatal nursery and to verify that these personnel are authorized tocare for infants, while also creating a verified data record. The onlyadditional equipment to that just described needed is a scanner unit inthe newborn nursery.

[0144] In this implementation, the identifying audio signal which isspecific to the patient (again, preferably a three note chord played insequence) is assigned to the mother in labor. When the baby is born, thebaby is also assigned a unique identifying tone sequence which isgenerated in response to scanning a barcode carried by the baby's namecard on the baby's bassinet. In the case of multiple live births, eachbaby receives a unique identifying tone sequence. For example, the samechord could be used but with a different suffix or ending (e.g.,chord-one, chord-two, chord-three).

[0145] The nurse must have a barcode bearing badge and when the nursetakes the newborn from the mother, the nurse's badge is scanned by thenurse through the barcode scanner, followed by scanning of the baby'sname card from the bassinet and next followed by scanning the baby'sbarcode on a wristband or legband, and the baby's three-tone sequence isgenerated after all of these scanning operations are completed andplaying of this sequence confirms that the nurse is authorized to takethe baby to the nursery. It is noted in contrast to an alarm or thelike, the tone sequence is soothing and reassuring.

[0146] When the nurse, baby and bassinet arrive at the nursery, thenurse scans her barcode badge, followed by the bassinet barcode on thebassinet. The corresponding three tones, i.e., the three tone chord,will then be generated, confirming that the assigned nurse for theinfant brought the infant into the nursery. The basic program or processverifies and then records in the database the various events that occurand the time at which the events occurred.

[0147] When it is time for the nurse to take the baby from the nurseryto the mother's room, the nurse scans her bar coded badge through thescanner at the nursery, followed by the baby's name card on thebassinet. Again, the three tones are emitted, indicating that anauthorized nurse is taking the infant from the nursery.

[0148] In accordance with a further embodiment of the invention, theinvention is used to assist verification of medications to be taken by apatient on an outpatient basis. In this embodiment, which is illustratedschematically in FIG. 6, a laser barcode scanner and speaker unit 180similar to those described above (or an equivalent unit,) are located inthe patient's home, indicated at H, and linked to a modem 182 to bemonitored by a home health agency or to function with a modem as a“stand-alone” in conjunction with a portable computer 184 such as apersonal data assistant (PDA) or a pocket computer. The tone recognitionsoftware generally described above would be installed on computer 184and would be programmed to recognize the barcodes on the patient'smedication bottle, packet, pill box or like container or carrier. In anadvantageous embodiment, further programming would include a medicationscheduler which would provide feedback to the patient about timing ofthe medication to be taken. For example, the program could provide foremitting the patient's identifying tone when the medication containerhas not been scanned within a predetermined period (e.g., two hours).

[0149] In operation, the process would begin with the treating physicianwriting an order for medication on the patient's prescription. Thepharmacy would receive the order for the patient and dispense themedication as assigned to a patient specific barcode on the medicationcontainer. The container with the barcode would then be given to thepatient. The patient would take the bar-coded medication container tothe scanner unit 180 and provide for scanning thereof. A tone sequenceor like audio signal, specific to the particular patient as describedabove, would be emitted thereby indicating that the medication containerhad not been scanned in the past, e.g., two hours. In an advantageousembodiment, the system would be programmed to provide specific timewindow guidance as to the taking of the medication, i.e., guidance as towhat medication was to be taken and within what time window, withtolerances being programmed in based on input from the pharmacist orhealth care provider. In any case, the program in computer 184 recordsand verifies that the medication container was scanned by the patientand records the medication and the time of day for later reporting. If,as shown in FIG. 6, the system is linked by modem 182 to a home healthagency, the report can be sent automatically to the responsible partiesvia a cordless telephone link.

[0150] It will be understood that while in the foregoing description,patient photographs and other patient identifiers are used on the sourcedocument or card carrying the barcode that is scanned to call up thepatient record and/or the audio signal file, other identifiers, whichare individualized for a particular patient, can also be employed.Further, while including both a patient photograph and barcode on thepatient card has obvious advantages, a single patient identifier can beused, for example, to call up the audio signal file containing the audiosignal assigned to the particular patient. Other patient identifiers oridentifying processes that can be used for this purpose, and otherpurposes, include retinal scanning, fingerprint scanning, iris scanningand subcutaneously implanted microchip scanning for individuals whorequest and consent to such devices for medical care reasons. Thepatient identifier would be scanned or read by a scanner or reader,preferably located in the treatment room as previously described, so asto trigger the playing of the patient specific audio signal when apatient identification or patient match was established by the scanningoperation.

[0151] Turning to yet another aspect of the invention, although a checksheet as described above can be used in the various applications of theinvention (after suitable modification to adapt the sheet to theparticular application), in accordance with this further aspect of theinvention, an improved check sheet is provided which is shownschematically in FIG. 7 and is generally denoted 190. As shown, thecheck sheet 190 has a first barcode 192 at the top middle portion of thecheck sheet, and a second barcode 194 at the lower left portion of thecheck sheet. As discussed above, a check sheet functions in radiationtherapy as a manual quality assurance tool in real-time. In theillustrated embodiment, the barcode 192 is fixed to the top of the pageand contains the patient's radiation therapy (RT) number with a Qsuffix. In contrast, the barcode 194 is removably affixed, e.g., by anadhesive, is located at the lower left corner of the check sheet 190 andcontains the patient's RT number with a P suffix. Barcode 194 can bepeeled from the check sheet and applied to, i.e., stuck on, thepatient's identification photo, chart, identification card oridentification band at the time of simulation (e.g., virtual,fluoroscopic, clinical).

[0152] When the applied stick-on barcode 194 (photo, chart, I.D. card orpatient band) is scanned, the patient's personal audio signal file isactivated, i.e., made audible. As indicated previously, in a preferredembodiment, the audio signal is known and recognized by the patient andthe radiation therapy technologists (R.T.T.s) or other medicalpractitioner or caregiver. Scanning the fixed barcode 192 at the top ofthe check sheet 190 generates the same audio signal, confirming that thestick-on barcode 194 matches the fixed barcode 192 at the top of thecheck sheet 190. The check sheet 190 can be used in in-patientmedication delivery and infant identification such as those describedhereinabove, with I.D. bands, cards, badges and medication check sheetverification. The check sheet 190 can also be used in the outpatientmedication compliance system discussed previously.

[0153] The check sheet 190 minimizes the potential for mismatchedbarcodes because it can be assured that the patient's number is the sameon both barcodes 192 and 194. Use of check sheet 190 is a one-stepprocedure which optimizes the probability of correctly applying thepeeled barcode label to the correct patient record. The check sheetserves as an additional safety net in the event other verificationsystems are inoperative.

[0154] The invention has principally been described above with respectto the application therefor to radiation therapy and although otherapplications have also been described, there are still otherapplications of importance. One of these is in the field ofchemotherapy. The system used for this application would includeanywhere from one to many individual stations. The hardware used in atypical station of such a system is shown in FIG. 8 and is comprised ofa computer 200, a touch-screen monitor 202, a keyboard 204, a mouse 206,two speakers 208 and 210, a barcode scanner 212, a laser or dot-matrixprinter 214, and a barcode printer 216. In an advantageousimplementation, all of this equipment is located on a single computerstand (not shown). The laser/dot-matrix printer 214 is used for printingof reports generated by the computer program. The barcode printer 216 isused in printing of barcode labels for new patients to be treated.

[0155] Referring to FIGS. 9(a) to 9(d), there are shown the basic stepsin a preferred embodiment of the treatment verification and recordmethod of this aspect of the invention. However, before consideringFIGS. 9(a) to 9(d), it will be understood that when a new patient is toreceive chemotherapy, the process begins with assembly of a new patientchart. The steps involved are as follows:

[0156] Patient information (name, ICD-9 diagnosis, and so on, asrequired) is entered into the computer 200 for the new patient.

[0157] The barcode printer 216 print out two barcode labels for thepatient, one for the front of the patient chart and the other to beplaced on the patient “flow sheet” (which is equivalent to the “checksheet” described above). This enables the system to later verify thatthe patient chart and the flow sheet always belong to the same patient.

[0158] The laser printer 214 prints out labels for the drug syringesused in the chemotherapy process. A nurse indicates how many treatmentsare planned for the patient and printer 214 prints out the complete setof labels for all treatments for this patient. Pre-printed labels arethen placed inside the patient chart. In this regard, one label is usedfor each treatment session as the chemotherapy drug is prepared andplaced into the syringe for the patient. The printed label includes thepatient name and, in a preferred embodiment, a barcode as well so as toallow the system to later verify the patient chart, flow sheet, andsyringes all are for the same patient just prior to treatment delivery.

[0159] Turning now to FIGS. 9(1) to 9(d), in a first step (block 220),the patient arrives for treatment. Although the next step (block 222)may have been done hours earlier in the day, the patient chart is pulledand treatment information obtained. In the next step (block 224), thesyringe filled with appropriate chemotherapy drug and the pre-printedlabel described above is placed on the syringe.

[0160] As a next step (block 226), the patient is taken to a treatmentroom.

[0161] In the patient room, the nurse enters treatment room with patientchart (block 228) and scans chart barcode (block 230) and flow sheetbarcode (block 232). The patient specific audio signal is generated at,in this preferred embodiment, the left speaker 208 (block 234) therebyallowing the patient to verify that it is their chart. The system alsoverifies on the screen of computer 200 that the two barcodes correspondto each other, i.e., that the patient chart and flow sheet are for samepatient. The actual sequence preferably provides that the nurse select atreatment chair or regime from the touch-screen monitor 202 and indicatethat a new patient has arrived for treatment, followed by the twobarcodes being scanned and the matching audio signal being generated. Atthis point, the system would then display the patient name to the nurse,thereby providing a visual verification of the patient name.

[0162] In the next step, indicated by block 238, the patient is hookedup to an IV and some pre-treatment drugs administered. These drugs areanti-nausea, dehydration and like drugs. In one implementation of thisembodiment of the invention, these drugs are also barcoded as well andare scanned at a scanning station prior to delivery. This would aid incharge capture by providing all drugs that are delivered in connectionwith a procedure are scanned into the system.

[0163] In the next step (block 242), the pre-chemotherapy treatment isadministered. The pre-treatment drugs are normally administered forapproximately one hour. The nurse sets up a “timing bag” at the sametime, which causes an alarm to go off when pre-treatment drug deliveryis completed. To assist here, a countdown timer is advantageouslyprovided so as to enable the nurse to get an overview of each patient,their treatment status (“pre-chemo” or “chemo”), and the time remaining.After hanging the timing bag, the nurse would just select theappropriate patient chair on the touch-screen 202 and start a countdowntimer to provide an alert as well as an indication as to when thepre-treatment is completed. As indicated by block 244, the nurse wouldnormally leave the room during this period.

[0164] As set forth above, when pre-treatment is complete an alarm goesoff. The nurse then retrieves patient pre-filled syringe and enterstreatment room again with the patient chart (block 248). The patientchart, flow sheet, and syringe are scanned by scanner 212 and thepatient specific audio signal is generated in response. Morespecifically, as indicated in FIG. 9(c), the barcode label on thepatient chart is scanned first (block 250), the barcode label on theflow sheet is then scanned (block 252), and the patient specific audiosignal is generated at the left speaker (block 254). The barcode labelon the syringe is then scanned (block 256) and a patient specific tonegenerated at the right speaker (block 258) thereby enabling patientverification. This also verifies that all barcodes are assigned to thesame patient and this, of course, includes the syringes. For high-riskpatients (those with specific ICD-9 diagnosis or those flagged manuallyby the nurse during patient registration), the system also provides aprompt for a verification nurse to enter his or her badge or otheridentifier or initials at the station to indicate that someone hasverified the drugs prior to administering the treatment. This simplyadds an additional cross-check for high risk situations.

[0165] At this time, the nurse is able to start a countdown timer ifdesired for treatment delivery and the chemotherapy starts (step 260).

[0166] Once treatment is completed (block 262), the nurse selects apatient chair on touch-screen 202 and indicates that the treatment iscompleted. As indicated by block 264, the barcode labels on the patientchart and the flow sheet are scanned by scanner 212 but no audio signalis generated as this is not required for this step. A report can begenerated at this time and printed in real-time to indicate the actualtreatment given as well as the previous treatment history and thetreatments remaining for the particular patient (block 266).

[0167] It will be appreciated from the foregoing that reports can begenerated from the computer station indicating the particular patientsthat have been treated during a given time frame. The billing secretarycan use this to verify that all patients treated for a given day werebilled appropriately. In addition, in a preferred implementation,billing information is transferred electronically in real-time followingtreatment completion to a commercial medical billing software systemacross a network. This latter approach captures all chemotherapy chargeselectronically as they occur without requiring manual efforts alone, totrack all of the billing.

[0168] It will be appreciated that all of the steps outlined above inconnection with FIGS. 9(a) to 9(d) are not new and although a number ofadvantages of the invention should be apparent from the foregoing, it isbelieved to be helpful to contrast the treatment of FIGS. 9(a) to 9(d)with typical current treatment practice.

[0169] In a typical chemotherapy treatment, one nurse hand labels blankpeel-off labels, and a schedule and chart are used to mix the requireddrugs. After the drugs are mixed, the syringe to be used is labeled withthe patient name and the name of the drug (e.g., Adriamycin). Thelabeled syringe is placed next to the chemotherapy hood. The patient isnext escorted into the infusion area and seated in the chair. Vitalsigns are taken and they are typically recorded on a blank scrap ofpaper for later transfer to the flow sheet of the patient's chart. Thedrugs (e.g., Zofran and Decadron) are started and during this period thenurse transfers the vital signs from the scrap of paper to the flowsheet. The “timing” bag drips in so as to delay the alarm referred toabove and the infusion pump sounds the alarm when the bag runs out,indicating that it is time for the chemotherapy treatment to begin. Atthis point, the nurse hears the alarm and injects the syringe into thebag. The nurse uses then writes the drug name on the bag in “Sharpie”indelible marker, the bag is hung and the infusion rate is programmedinto the pump. After the patient receives the infusion, the nurse ornurses must document the charges manually on several forms.

[0170] In the treatment method of the invention, the patient chart isused to mix the drugs and, as indicated previously, the registrationprocess results in the printing of two barcodes, one for the chart andone for the flow sheet as well as the correct number of peel-off labelsfor the particular drug course or protocol. As set forth above, afterthe drugs are mixed, the syringe is labeled with a barcode label whichincludes the patient name, the name of the drug, etc. (e.g., “JaneSmith, Adriamycin, cycle 2 of 4” or “Jane Smith, Cytoxan, cycle 2 of4”).

[0171] The next part of the procedure is the same as in conventionaltreatment through the seating of the patient in the treatment chair. Atthis point, the front cover of the patient chart would be scanned andthe audio signal generated in the left speaker. The chart is thenopened, the flow sheet scanned and the audio signal generated in theright speaker. The vital signals are then taken and recorded in thechart on the flow sheet, in real time.

[0172] As in the currently used procedure, the drugs are then startedand the “timing” bag infuses to delay the alarm, the infusion pumpsounds when the bag runs out and the nurse hears the alarm indicatingthat it is time for chemotherapy to start. At this point, the nurseinjects the previously labeled syringe or syringes into the bag which islabeled with a “Sharpie” marker as in the conventional process. At theend of the treatment, the nurse scans the patient chart and flow sheetand the above-mentioned billing prompt is generated (e.g., Bill patient?(Mrs. Jane Doe) yes/no). A positive response to the billing promptgenerates a hardcopy sheet which is initialed by the nurse, signifyingthat the sheet agrees with the flow sheet and the signed hardcopy sheetis sent to billing.

[0173] In accordance with a further aspect of the invention, a medicalbilling system and method are provided which is specifically designed toensure capture of charges that are sometimes missed or overlooked inbilling for medical services. The system provides for logging in of thepresence of a patient treatment chart or check sheet at a particularlocation such as a treatment room. The presence of the chart at thatlocation can be determined, for example, based on an event involving thechart such as scanning of the chart by a scanning device at thatlocation, as described above, or by using a tracking system which keepstrack of the location of the document. When the patient treatment chartis determined to be located in the treatment room, the presumption isthat the patient is being treated and thus that services are beingrendered that should be billed for. By logging the presence of the chartat the treatment room into the billing system, the system is alerted tothe fact that treatment has occurred or will occur and that a bill forthe treatment should be generated. If no bill is generated, the billingsystem is queried as to why, and an inquiry is made.

[0174] Although the invention has been described above in connectionwith generating a characteristic audio signal in response to a matchwith an identifier, and this has important specific advantages, in analternative embodiment, a visible indication or signal could be providedin a match situation, e.g., by energizing a light source. Further, aparticular visual pattern unique to the patient and known to him or hercould be generated in a match situation.

[0175] Turning to a more general consideration of the invention, itshould be appreciated from the foregoing that the core method or processof the invention is not a primary verification tool. The inventionserves to provide a secondary verification opportunity or documentationaffirmation of other verification processes and does not replace orundermine other existing verification methods. One key differencebetween the invention and other systems or methods is that the inventionenlists the patient in the identification process in a positive way. Theenlistment is done in an aesthetically pleasing manner, with theabove-described tones being emitted from the background. In this regard,it is noted that foreground stimuli would only further distract thecaregiver and/or patient who is already bombarded by stimuli fromnumerous automated systems. Further, the invention does not contributeto automation induced user complacency because the identifying toneemployed in the preferred embodiments of the invention, is a pleasingsound that differs from the beeps and alarms associated with othermedical technologies which are designed on management by exceptionstrategies. The system awards the user for doing the right thing, ratherthan penalizing the user for a misstep, which is how other systems work,and all this in view of the patient. Moreover, the tone is intended toprovide specific reassurance, not alarm, in the listener. The inventionpreferably uses a database of protected audio files that produce a tonesequence specifically assigned to the individual patient. The listenerthen recognizes his or her tone chord on a long-term basis.

[0176] As more therapies move in the direction of chronic conditionmanagement as opposed to acute care management, the advantages of theinvention will become even more apparent. This is particularly true inan environment noted for severe shortages in nursing personnel as wellas in the area of high technology specialties such as radiation therapy,where new or temporary personnel are brought in to care for clients andpatients with complicated chronic medical conditions. Deliveringincorrect medication or treatments in highly specialized care settingscan have a far more serious consequence in the medical environment oftoday than it would have just a few years ago. As treatments become muchmore tailored to an individual's disease or predisposition to a disease,the consequences of delivering even one wrong treatment may be far moretoxic to the patient. Specific, targeted treatments often have anarrower therapeutic window, and may be beneficial only when deliveredto a certain patient under certain conditions. The invention is flexibleenough to be able to emit confirmatory tones under these refinedscenarios, i.e., to confirm that the patient is the correct patient, thetreatment chart is the right chart, and the sequencing or timing of thetreatment is correct, and, as indicated above, this is all done in thebackground through the use of pleasant audio signals which can berecognized internationally, independently of language differences. It isnoted that the chord sequences selected for international distributioncould be derived from major chords for individuals of western backgroundor a western country of origin, but could also be matched to the countryof origin by using in the tone assignments, minor chords or otherculturally more familiar chord-based tone sequences for individuals fromnon-western backgrounds or countries of origin. Further, a pre-chordsequence preferably provided that would serves as the geographic/year oforigination of the tone assignment.

[0177] In some of the preferred embodiments of the invention describedherein, two speakers are provided in the treatment room on oppositesides thereof. It has been found that “panning” of the audio signalacross the room, i.e., playing the sound on one side of the room inresponse to a first scan and then playing the sound of the other side ofthe room in response to a second scan is advantageous. In this regard,panning helps with recognition of the audio match event, bydifferentiating the event from other sounds in the treatment room and bydifferentiating a repeat scan of the photo from scanning of the photoand then the check sheet. Preferably, the length of the tone chord is 2to 3 seconds for a monosound setup and {fraction (1/2)} to 2 seconds forthe panning embodiments. These times are designed to provide the mostefficient way to match task-critical entries in the shortest time andare based on maximizing discrimination based on tone contour and melodyrecognition.

[0178] It will be understood that a safety system ideally should bedesigned so that a successful recovery procedure can be implemented ifthe primary process should fail. The present invention does this becausethe invention serves to provide positive confirmation. In this regard,in a preferred embodiment, if the scanned patient or treatmentdemographics do not match, resulting in no tone sequence generation, theuser hears nothing. The absence of the confirmatory tone sequence iswhat prompts the caregiver or patient to question the treatment that isabout to be delivered. This is an important point because if the systemof the invention should fail for any reason, the patient or caregiver isprompted by the absence of an audio confirmation to investigate further.The system of the invention is not an alarm that prompts the user toinvestigate because if the alarm should fail, the user does not knowthat the safety mechanism has failed. If the system is silent when atone is expected, the user becomes more vigilant.

[0179] Although the invention has been described above in relation topreferred embodiments thereof, it will be understood by those skilled inthe art that variations and modifications can be effected in thesepreferred embodiments without departing from the scope and spirit of theinvention.

What is claimed:
 1. A method of verification of the identity of apatient, said method comprising: scanning a patient identifier whichidentifies the patient to be treated; and generating a characteristicaudio signal, previously assigned to the patient, in response to thescanning of the patient identifier when there is a match between thescanned patient identifier and a stored identifier for the patient.
 2. Amethod according to claim 1 , wherein the audio signal is known to atleast one of (i) the patient and (ii) an authorized caregiver for thepatient.
 3. A method according to claim 1 wherein the patient isundergoing medical treatment and the method further comprises at leasttemporarily withholding treatment of the patient if any audio signalgenerated in response to the scanning of the patient identifier is notthe characteristic audio signal assigned to the patient.
 4. A methodaccording to claim 1 wherein the patient is a newborn baby and thescanning is carried out to ascertain whether the newborn may properly beremoved from its current location.
 5. A method according to claim 4wherein an approved caregiver for the baby is assigned a badge includingan identifier and the badge must also be scanned by the caregiver beforethe baby can properly be removed by the caregiver from said currentlocation.
 6. A method according to claim 4 wherein the patientidentifier is carried by a name card on the bassinet for the baby.
 7. Amethod according to claim 6 wherein the patient identifier is alsocarried by an identification band worn by the baby.
 8. A methodaccording to claim 1 wherein at least one further identifier, inaddition to said patient identifier, is scanned for a match and saidcharacteristic audio signal is generated only after a match is found ineach instance that an identifier is scanned.
 9. A method according toclaim 1 wherein said characteristic audio signal is generated only whena match is found in each instance and only when the matches occur in apredetermined sequence.
 10. A method according to claim 1 wherein, inaddition to said scanning of the patient identifier, a caregiveridentifier is scanned to determine whether the caregiver identifier isthat of an authorized caregiver for the patient and a check sheetidentifier is scanned to determine whether the check sheet is that ofthe patient, and wherein said characteristic audio signal is generatedonly after a match is provided in every instance.
 11. A method accordingto claim 10 wherein said characteristic audio signal is generated onlywhen the identifiers are scanned in a predetermined sequence.
 12. Amethod according to claim 10 wherein a medication identifier associatedwith a medication about to be given to the patient is scanned todetermine whether the medication is that intended for the patient and afurther, matching characteristic audio signal is generated when there isa match.
 13. A method according to claim 1 wherein the patientidentifier is carried by a medication container for medication for thepatient.
 14. A method according to claim 6 wherein the patientidentifier is also carried by a medication chart on which the physicianfirst writes an order for the medication and both the medicationcontainer and the mediation chart are scanned to determine whether saidcharacteristic audio signal is generated in response thereto.
 15. Amethod according to claim 1 wherein said scanning takes place in apatient dwelling and said patient identifier is carried by a containerfor a medication which is to be taken by the patient and which isprepared by a pharmacy.
 16. A method according to claim 15 wherein aprescription for the medication, including the name of the patient, isinitially written by a physician for the patient, wherein theprescription is received by the pharmacy, and wherein the pharmacydetermines the corresponding scannable patient identifier assigned tothe patient and dispenses the medication in said container carrying saidpatient identifier.
 17. A method according to claim 1 wherein saidscanning of said patient identifier comprises scanning of a medicaldevice for delivering a medication to the patient.
 18. A methodaccording to claim 17 wherein said medical device comprises a syringe.19. A method according to claim 1 wherein said patient identifier iscarried by a label produced by the caregiver.
 20. A method according toclaim 19 wherein the caregiver initially dispenses a plurality ofidentical patient identifier carrying labels at the same time.
 21. Amethod according to claim 20 wherein said method is used in chemotherapytreatment of the patient and said labels are applied to container forall drugs used in the chemotherapy treatment, to all syringes used inthe chemotherapy treatment and to at least one patient identificationmember.
 22. A method according to claim 1 wherein said scanning ofpatient identifier comprises scanning of a patient identifying memberselected from the group consisting of a patient photograph, a patienttreatment chart, a patient identification card and an identificationband worn by the patient.
 23. A method according to claim 22 wherein atleast two of the patient identifiers of said group are separatelyscanned.
 24. A method according to claim 1 wherein said scanning iscarried out using a scanning device selected from the group consistingof a coded marking scanner, a retinal scanner, a fingerprint scanner, aniris scanner and a scanner for a subcutaneous microchip.
 25. A methodaccording to claim 24 wherein said patient identifier comprises abarcode and scanning of said barcode is carried out using a codedmarking scanner comprising a barcode reader.
 26. A method according toclaim 1 wherein said characteristic audio signal comprises a non-verbalsound pattern.
 27. A method according to claim 26 wherein saidnon-verbal sound pattern comprises a three tone chord.
 28. A methodaccording to claim 27 wherein the duration of said chord is about 2 to 3seconds.
 29. A method according to claim 27 wherein the chord isgenerated at two different times, in close sequence, from two spacedlocations and the duration of said chord is about ½ to 2 seconds.
 30. Amethod according to claim 1 wherein scanning of the patient identifiercomprises scanning two different identification members carrying thepatient identifier and results in the generation of two separatematching characteristic audio signals at two different spaced apartlocations in a treatment room when the patient identifiers carried bythe two members match said stored patient identifier.
 31. A methodaccording to claim 30 wherein the two patient identifiers are scanned bytwo different separate scanning devices spaced apart in the treatmentroom.
 32. A method of verification of the identity of a patientundergoing treatment administered by a medical treatment practitioner ina treatment room, said method comprising: providing an identifyingelement for the patient including a patient identifier capable of beingread by a reader device located within the treatment room; causing thepatient identifier to be read by said reader device in the treatmentroom; generating a characteristic audio signal, previously assigned tothe patient and known to the patient, in response to the reading of saididentifying element when there is a match between the patient identifierand a stored identifier for the patient; and at least temporarilywithholding treatment of the patient if any audio signal generated inresponse to reading of the patient identifier by the reader device isnot the characteristic audio signal assigned to the patient.
 33. Amethod according to claim 32 wherein said identifying element comprisesan identifying member selected form the group consisting of a patientphotograph, a patient treatment chart, a patient treatment verificationsheet, a patient identification card and an identification band worn bythe patient.
 34. A method according to claim 32 wherein said readerdevice comprises one of a coded marking reader and a fingerprintscanner.
 35. A method according to claim 32 wherein first and secondreader devices are provided in the treatment room as part of aworkstation which also includes first and second spaced audio speakersfor generating said characteristic audio signal, wherein at least atreatment practitioner is required to scan different patient identifyingelements each including said patient identifier at the first and secondreaders, respectively.
 36. A method according to claim 35 wherein one ofsaid patient identifying elements comprises a patient chart including aphotograph of the patient.
 37. A method according to claim 35 whereinone of said patient identifying elements comprises a paper patienttreatment verification sheet.
 38. A method according to claim 32 whereintwo medical practitioners carry out the treatment and wherein thetreatment that the patient is to undergo includes an automatic setupportion which is carried out automatically under computer control andwherein access to the automatic setup portion is permitted only if bothmedical practitioners are designated as having automatic setupprivilege.
 39. A method according to claim 32 wherein the method is usedin a control system to control, based on preselected criteria, access toan existing automatic download treatment system for a radiationtreatment device which automatically transfers prestored patienttreatment parameters to the radiation treatment device.
 40. A methodaccording to claim 39 wherein said criteria include verification ofprivileges of the medical practitioners responsive to logging by thepractitioners onto the control system by effecting scanning of a patientchart by one of the reader devices.
 41. A method according to claim 32wherein the patient identifier is carried by a container for amedication for the patient and the characteristic audio signal is knownboth by the patient and the medical treatment practitioner so that boththe patient and the practitioner can be assured by hearing thecharacteristic audio signal that the correct medication container hasbeen provided for the patient.
 42. A method according to claim 41wherein the patient identifier is applied by an in-hospital pharmacy tothe medication container and corresponds to a patient identifierpreviously assigned to that patient during pre-treatment processing. 43.A patient treatment check sheet containing at least a first field forentry of at least the name of the patient to be treated and a secondfield including printed patient treatment parameters and blanks to befilled in during the course of treatment of the patient, said checksheet further comprising at least one fixed patient identifier includingcharacteristic coding adapted to be scanned by a scanning device toprovide reading thereof and at least one removable patient identifierincluding said characteristic coding and adapted to be affixed to afurther element to be used in the treatment of the patient.
 44. Apatient treatment check sheet according to claim 43 wherein said furtherelement is patient identification member selected from the groupconsisting of a patient photograph, a patient chart, a patient treatmentverification sheet, a patient identification card, a patientidentification band and a combination of a patient photograph and apatient chart.
 45. A verification system for use in verification of theidentify of a patient about to undergo medical treatment administered tothe patient in a treatment room under the control of at least onemedical practitioner, said system comprising: a verification workstationincluding electronic storing means for storing a patient identifierassigned to the patient to be treated; at least one scanning device forscanning a scannable patient identifier which uniquely identifies thepatient to be treated; and means for generating a characteristic audibleoutput assigned to the patient to be treated and unique to the patient,responsive to matching of the patient identifier scanned by saidscanning device and the patient identifier stored by said electronicstoring means at said verification workstation.
 46. A system as claimedin claim 45 wherein said scannable patient identifier comprises a barcode carried by a treatment chart for the patient.
 47. A system asclaimed in claim 46 wherein said system includes first and secondscanning devices, located at spaced locations within said treatmentroom, for separately scanning scannable patient identifiers carried,respectively, by (i) a treatment chart and (ii) at least one otherelement associated with the patient to be treated.
 48. A method offacilitating billing for medical treatment services involving treatmentof a patient wherein a patient treatment chart is used in conjunctionwith the treatment of the patient, said method comprising the steps of:logging onto a computerized billing system when the patient treatmentchart is located at a predetermined location in a treatment facility;and generating a billing alert in response to said logging on step so asto ensure patient treatment provided at said location will be billedout.
 49. A method as claimed in claim 48 wherein said logging on stepcomprises logging on responsive to use of a scanning device located atsaid predetermined location to scan a patient identifier on said patienttreatment chart.